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Ginseng total sub-glycosides orally disintegrating tablet in treatment of chronic stable angina pectoris (syndrome of Qi deficiency and blood stasis ): a multi-center, randomized, double-blind, placebo controlled phase II trial.

Ginseng total sub-glycosides orally disintegrating tablet in treatment of chronic stable angina pectoris (syndrome of Qi deficiency and blood stasis ): a multi-center, randomized, double-blind, placebo controlled phase II trial.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001190
Enrollment
Unknown
Registered
2011-02-25
Start date
2011-03-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stable Angina

Interventions

Low dose group:Ginseng total sub-glycosides orally disintegrating tablet (0.35g / piece, Ginseng total sub-glycosides containing about 37mg / piece), the mouth sublingual 3 times a day, Once a piece
the Placebo oral disintegrating tablets, oral sublingual 3 times a day, Once a piece for 8 weeks.
High dose group:Ginseng total sub-glycosides orally disintegrating tablet (0.35g / piece, Ginseng total sub-glycosides containing about 37mg / piece), the mouth sublingual 3 times a day, Once 2 piece
Placebo group:The Placebo oral disintegrating tablets, oral sublingual 3 times a day, Once 2 piece for 8 weeks.

Sponsors

Guangdong Provincial Hospital of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Age 18 to 65 years; (2) Classification of angina severity was grade II-III; (3) Angina attack can use the available nitrates mitigation; (4) To complete the ECG exercise stress test, and positive test results; (5) Informed consent, and written informed consent.

Exclusion criteria

Exclusion criteria: (1) Occurred within 3 months of Myocardial Infarction or history of Unstable Angina, or had coronary revascularization (Bypass surgery or Angioplasty); (2) Combined with other heart disease, neurosis, menopausal syndrome, hyperthyroidism, cervical disease, Biliary-cardiac syndrome, stomach - esophageal reflux disease or Esophageal hiatal hernia and other diseases may cause chest pain; (3) The following abnormalities of resting ECG: complete left bundle branch block, preexcitation syndrome, ventricular pacing rhythm, ST segment depression more than 0.1mv or left ventricular hypertrophy; (4) Merger of uncontrolled or symptomatic heart failure or echocardiography prompted left ventricular ejection fraction = 2 times the upper limit of normal reference values; (8) Abnormal renal function (serum creatinine> upper limit of normal reference values.); (9) Complicating the respiratory system, hematopoietic system or malignant tumor and severe primary disease; (10) Pregnant women, lactating womenor women of child-bearing age have fertility requirements; (11) Mental illness, or cognitive dysfunction; (12) The expected patients who are poor compliance, lack of regular visits, or can not be completed in accordance with the requirements of a doctor patient diary cards; (13) Within the last 3 months have participated in other clinical trials or have received this randomized clinical trial; (14) The researchers perceived there is not suitable to participate in the trial of other cases.

Design outcomes

Primary

MeasureTime frame
Treadmill test standard;

Secondary

MeasureTime frame
Echocardiography;Standards of TCM symptoms;ECG standard;Angina episodes;

Countries

China

Contacts

Public ContactHuanlin Wu
wuhuanlinboshi@yahoo.com.cn+86 13822212111

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026